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Lawmakers release new version of 21st Century Cures legislation

Yesterday, a bipartisan group of representatives from the House of Representatives’ Energy and Commerce Committee released a new discussion draft of the 21st Century Cures initiative. This draft is the latest step in the Committee’s year-long attempt to accelerate new medical innovations and improving the way they are brought to market. According to a release from the Committee, the discussion draft includes provisions that:

Incorporate the patient perspective in the discovery, development, and delivery process.

Increase funding for the National Institutes of Health, both through reauthorization and $10 billion over five years in mandatory funding, starting in FY 2016.

Foster development of treatments for patients facing serious or life-threatening diseases.

Repurpose drugs for serious or life-threatening diseases and conditions.

Modernize clinical trials.

Break down barriers to increased collaboration and data sharing among patients, researchers, providers, and innovators.

Help the development of personalized and precision medicines so the right patient can receive the right treatment at the right time.

Provide for continued work in the telehealth space.

Advance a truly interoperable health care system.

Provide clarity for developers of software products used in health management and medical care.

Of note, is what is not in this draft. FIrst, the discussion draft (which I should point out is only half the length of the version released in January) , doesn’t include expansion of exclusivity for branded pharmaceuticals – something that was seen as a barrier for securing bipartisan and broad stakeholder support. It should be pointed out though that the draft has placeholder language that may leave the door open for exclusivity incentives. Second, the draft does not address how to expand Medicare to pay for telemedicine. On this point, a bipartisan group of eight members of the Energy and Commerce Committee, led by Rep. Greg Harper (R-Mississippi) are hard at work to come up with legislative language that spurs adoption of telemedicine but that doesn’t cost CMS (and taxpayers) billions of dollars.

While the schedule is fluid, Energy and Commerce Chairman Fred Upton (R-Michigan) has stated that he wants to mark up the bill before Congress takes its Memorial Day recess and schedule a vote in the House of Representatives in June. Today, the Committee held a hearing today to take testimony on the draft from HHS and FDA.

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